Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Hematology ×
3,297 results
529–552 of 3,297
Search insights Median review: 73d Cleared: 100% Top manufacturer: Helena Laboratories Lead specialty: Hematology
Cleared Feb 10, 2005
HEMOCHRON SIGNATURE ELITE
K050016 · JPA
International Technidyne Corp.
Hematology · 37d
Cleared Feb 10, 2005
COULTER LH 750 HEMATOLOGY ANALYZER
K050057 · GKZ
Beckman Coulter, Inc.
Hematology · 30d
Cleared Feb 09, 2005
HEMOSIL FACTOR XII DEFICIENT PLASMA
K043459 · GJT
Instrumentation Laboratory CO
Hematology · 56d
Cleared Jan 19, 2005
FLOWCARE PLG CD4 REAGENT
K043215 · GKZ
Beckman Coulter, Inc.
Hematology · 61d
Cleared Jan 10, 2005
CYTOVISION FOR CEP XY
K042542 · NTH
Applied Imaging Corp.
Hematology · 112d
Cleared Dec 22, 2004
PEFAKIT APC-R FACTOR V LEIDEN CONTROLS
K042760 · GGN
Pentapharm , Ltd.
Hematology · 78d
Cleared Dec 22, 2004
PEFAKIT APC-R FACTOR V LEIDEN
K042762 · GGW
Pentapharm , Ltd.
Hematology · 78d
Cleared Dec 22, 2004
HEMOSIL RECOMBIPLASTIN
K043184 · GJS
Instrumentation Laboratory CO
Hematology · 35d
Cleared Dec 15, 2004
ANEMIAPRO SELF-SCREENER
K042379 · KHG
Biosafe Laboratories, Inc.
Hematology · 105d
Cleared Dec 10, 2004
ENZYGNOST F+2 (MONOCLONAL) TEST KIT
K042687 · MIF
Dade Behring, Inc.
Hematology · 72d
Cleared Dec 03, 2004
HEPARIN DOSE RESPONSE CONTROLS, MODEL 306-20 POR
K043080 · JOX
Medtronic Vascular
Hematology · 25d
Cleared Dec 02, 2004
COATEST SP FVIII
K042576 · GGP
Instrumentation Laboratory CO
Hematology · 71d
Cleared Dec 02, 2004
DADE BEHRING HEPARIN CALIBRATOR AND CONTROLS
K042941 · GIZ
Dade Behring, Inc.
Hematology · 38d
Cleared Dec 01, 2004
CONTROL PLASMA N, PROC CONTROL PLASMA
K042333 · GGN
Dade Behring, Inc.
Hematology · 93d
Cleared Nov 29, 2004
TRIAGE D-DIMER TEST, MODEL 98100
K042890 · GHH
Biosite Incorporated
Hematology · 41d
Cleared Nov 29, 2004
FIBROTEK FIB
K042919 · GIS
R2 Diagnostics, Inc.
Hematology · 38d
Cleared Nov 23, 2004
FLOWCARE SYSTEM
K041882 · GKZ
Pointcare Technologies, Inc.
Hematology · 134d
Cleared Nov 19, 2004
COBE ANGEL WHOLE BLOOD SEPARATION SYSTEM
K042473 · JQC
Cobe Cardiovascular, Inc.
Hematology · 67d
Cleared Nov 05, 2004
LIQUICHEK RETICULOCYTE CONTROL (A)
K042836 · JPK
Bio-Rad
Hematology · 22d
Cleared Oct 29, 2004
MODIFICATION TO COULTER LH 500 HEMATOLOGY ANALYZER
K042724 · GKZ
Beckman Coulter, Inc.
Hematology · 28d
Cleared Oct 29, 2004
QC-BEADS
K042750 · NRF
Bioscreen, Inc.
Hematology · 25d
Cleared Oct 21, 2004
POLYMEDCO OC AUTO MICRO 80 FOB TEST
K041408 · OOX
Polymedco, Inc.
Hematology · 147d
Cleared Oct 21, 2004
CONTROL PLASMA N AND CONTROL PLASMA P
K042209 · GGN
Dade Behring, Inc.
Hematology · 66d
Cleared Oct 19, 2004
RETIC-CHEX FOR CELL-DYN
K042587 · JPK
Streck Laboratories, Inc.
Hematology · 27d